Applied Clinical Trials-09-01-2003

Applied Clinical Trials

Pediatric Subjects and Their Parents

February 15, 2004

Feature Article

Pediatric trials got a good report card from a survey that explored the motivators and experiences of young subjects and their parents.

EU to Put the IT into Clinical Trials

September 01, 2003

View from Brussels

As information technology becomes more important to clinical trials, the EU is discussing how IT should be included in clinical trials legislation.

Practical and Ethical Issues in Pediatric Clinical Trials

September 01, 2003

Feature Article

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

Multinational Clinical Trials: Breaking Language and Cultural Barriers

September 01, 2003

Feature Article

It is increasingly important for clinical trial personnel to break through the obstacles that language and culture present when conducting trials away from their home countries.

Bridging Strategies May Help Put Western Drugs on the Japanese Market

September 01, 2003

Feature Article

Restrictive regulations and cultural differences make regulatory approval in Japan elusive, but adopting new strategies may make that lucrative pharmaceutical market more accessible to non-Japanese companies.

Research and Access Issues Challenge Policymakers

September 01, 2003

View from Washington

FDA plans to rewrite rules governing electronic records while offering new policies to encourage risk-based regulatory approaches to application review and inspections.

2003 IT Solutions Addendum

September 01, 2003

Application, software, Web-based solutions, and more.